Continuous Glucose Sensors in Youth: Biobehavioral Study

描述(由申请人拟备)：为患有1型的青少年提供强化治疗 糖尿病(DM)产生更高的HbA1c和更频繁的严重 低血糖(SH)高于成人。连续血糖传感器的出现 (CGS)可以为这些年轻人带来医疗和心理上的好处。这个 调查人员提出，许多患者可能没有意识到这些好处， 患者和家属的心理社会特征会影响结果 在糖尿病治疗中加入CGS。为了最大限度地发挥CGS的治疗效果，我们 需要有关其血糖和心理方面的临床有用信息 以及心理因素对其治疗效果的影响。这 信息将有助于选择这项技术的候选人，并 协助病人和家属从其 使用。这项申请涉及四个具体目标：1.对该计划的评估 12个月的影响？S使用CGS设备(GLucoWatch传记作者，天鹅座， Inc.)HbA1G、Kovatchev低血糖指数及 严重低血糖；行为和心理的认同 使用CGS的后果；3.)代谢的心理社会预测因素分析 和心理结果；以及4)健康人群血糖谱的评价 未患糖尿病的青年，建立用于糖尿病治疗的标准血糖曲线 两组青年血糖谱的未来研究和比较 没有糖尿病。具体目标1至3将在 三种强化治疗方案的随机对照试验 基于不同的血糖监测方法：SMBG患者将接受 目前通过四到六次自我监测血糖检测进行强化治疗 每日；有反馈患者的CGS将通过使用CGS设备来增强SMBG 提供即时血糖反馈和高、低、快速下降的警报 水平；没有反馈的CGS患者将通过使用相同的CGS来增加SMBG 反馈和报警功能禁用的设备。病人和家长 将完成人口因素的定期评估和一般和 糖尿病特有的心理因素。统计分析将包括 多元方差分析、生存分析与个体成长 建模技术。具体目标4将通过研究一个 人口统计学上相似的240名健康儿童和青少年的样本 将在没有反馈的情况下使用GLucoWatch传记总共144小时 在两周的时间里。该项目的成果将促进临床采用 CGS技术。

DESCRIPTION (prepared by applicant): Intensive therapy for youths with type 1 diabetes mellitus (DM) yields higher HbA1c and more frequent severe hypoglycemia (SH) than for adults. The advent of continuous glucose sensors (CGS) could yield medical and psychological benefits for these youths. The investigators submit that many patients may not realize these benefits and that psychosocial features of patients and families will affect the outcomes of adding CGS to DM therapy. To maximize the therapeutic benefits of CGS, we need clinically useful information about its glycemic and psychological effects and about psychological influences on its therapeutic utility. This information would be useful in selecting candidates for this technology and for assisting patients and families in achieving positive outcomes from its use. This application addresses four specific aims: 1.) Evaluation of the effects of 12 month?s use of a CGS device (GlucoWatch Biographer, Cygnus, Inc.) on HbA1G, the Kovatchev Low Blood Glucose Index and the frequency of severe hypoglycemia; 2.) Identification of behavioral and psychological consequence of CGS use; 3.) Analysis of psychosocial predictors of metabolic and psychological outcomes; and 4.) Evaluation of glycemic profiles of healthy youths without DM, construction of a normative glycemic profile for use in future studies and comparison of the glycemic profiles of youths with and without diabetes. Specific Aims 1 through 3 will be addressed in a randomized, controlled trial of three intensive therapy regimens that are based on different glucose monitoring methods: SMBG patients will receive current intensive therapy with four to six self-monitored blood glucose tests daily; CGS with Feedback patients will augment SMBG by using a CGS device that gives immediate glucose feedback and alarms for high, low, and rapidly falling levels; CGS without Feedback patients will augment SMBG by using the same CGS device with the feedback and alarm functions disabled. Patients and parents will complete periodic assessments of demographic factors and general and diabetes-specific psychological factors. Statistical analyses will include multivariate analyses of variance, survival analysis and individual growth modeling techniques. Specific Aim 4 will be addressed by studying a demographically similar sample of 240 healthy children and adolescents who will use the GlucoWatch Biographer without feedback for a total of 144 hours during a two-week period. The project results will enhance clinical adoption of CGS technology.